Canadian Federal Court Clarifies Good Faith Requirement in Patent Prosecution
Lundbeck Canada Inc. v. ratiopharm Inc., 2009 FC 1102 (Mactavish, J.)

November 23, 2009

Steven B. Garland and Colin B. Ingram for Lundbeck Canada Inc. (Lundbeck)
Arthur B. Renaud for ratiopharm Inc. (ratiopharm)

In a proceeding under the Patented Medicines (Notice of Compliance) Regulations, the Federal Court recently held that there is a duty of candour on applicants in how they represent prior art during the prosecution of their patent applications.

The Plaintiff (Lundbeck) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to ratiopharm Inc. (Ratiopharm) regarding the drug mematime sold under the brand name EBIXA until the expiry of Canadian Patent No 2,426,492 (the ‘492 Patent) and 2,014,453 (the ‘453 Patent). Both prohibition applications were ultimately dismissed.

Among other things, ratiopharm alleged that the ‘492 Patent should have been deemed to been abandoned for failing to respond to an examiner’s requisition because the applicant breached its duty of good faith by misrepresenting the prior art in its response. The ‘492 Patent claimed a combination of two drugs.

In a requisition, the Examiner objected to the pending claims as being obvious because they claimed an aggregation of known compounds. In response, Lundbeck argued that the prior art “teaches away” from the pending claims with reference to four such prior references, and that the combination was not obvious. However, Lundbeck did not discuss a particularly relevant prior art reference, Wenk, in its response to this requisition.

The Court found that the Wenk reference was directly relevant, and did not “teach away” from the combination of the two compounds. Wenk disclosed that some of the relevant compounds retain their effectiveness when combined.  Since the applicant’s statements were not a fair representation of the prior art, the Court held that Lundbeck did not act in good faith when responding to the requisition of the examiner. The Court held that ratiopharm’s allegation that the ‘492 Patent was abandoned for failing to respond to an examiner’s requisition in good faith within the time limit was justified.

The Court also held in the alternative that ratiopharm’s allegations the ‘492 Patent was invalid for inutility was justified. The Court found that the patent did not contain the information required to satisfy the sound prediction test, and that the utility of the invention had not been proven as of the filing date.

The Court also found that ratiopharm’s allegation that it would not infringe the ‘492 Patent was justified. ratiopharm was planning to distribute one of the two drugs to be used in combination therapy, so the issue was whether ratiopharm would induce others to use the drug in an infringing manner in combination therapy.  Since the drug monograph contained no references to its use in combination therapy, there was little to suggest infringement.

With respect to the ‘453 Patent, the Court held that ratiopharm’s allegations of anticipation and obviousness were justified. The Court found more than one reference that anticipated all of the claims of the ‘453 Patent, and that an even larger list of references rendered the claims obvious.

By: Lauren Lodenquai and James Kosa, Deeth Williams Wall LLP